Proposed Data Collections Submitted for Public Comment and Recommendations, 42414-42415 [E7-15027]

Download as PDF 42414 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices guide the development of prevention and control strategies. Participation in the data collection is voluntary and there is no cost to respondents to participate in the survey other than their time. beliefs about HCV infection. The utility of using HCV nucleic acid testing (NAT), antigen-antibody testing and other testing modalities to identify seroincident (window period) infections will also be assessed. Knowledge of factors associated with acquiring hepatitis C virus infection is essential to respondents. The total annual burden for this project is expected to be 1600 hours. The information to be collected includes demographic data, risk factors for HCV infection, missed opportunities for prevention (including hepatitis A and B vaccination), access to medical care, and knowledge, attitudes, and ESTIMATED ANNUALIZED BURDEN HOURS Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Young injection drug users .............................................................................. 1600 1 1 1600 Dated: July 27, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7–15020 Filed 8–1–07; 8:45 am] agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Proposed Project [60 Day-07–0020] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the Coal Workers’ X-ray Surveillance Program (CWXSP) OMB # 0920–0020— Extension—The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The CWXSP is a federally mandated program under the Federal Mine Safety and Health Act of 1977, Public Law 95– 164. The Act provides the regulatory authority for the administration of the CWXSP, a surveillance program to protect the health and safety of underground coal miners. This Program requires the gathering of demographic and logistical information from coal mine operators, participating miners, participating x-ray facilities, and participating physicians. The Appalachian Laboratory for Occupational Safety and Health (ALOSH), located in Morgantown, WV, is charged with administration of this Program. Over the past two years, participation in the CWXSP has increased, which is reflected in this submission for renewal. Based on an average of 5,000 x-rays coming into the Program per year (each x-ray receives two readings), and using the average hourly wage rates taken from the Bureau of Labor Statistics, National Occupational Employment and Wage Estimates, the total annualized burden hours is 2,329. Physicians (B Readers) will fill out forms regarding their interpretations of the x-rays. Based on prior practice it takes the physician approximately 3 minutes per form. Physicians taking the B Reader Examination are asked to complete a registration form which takes approximately 10 minutes to complete. There are approximately 300 physicians each year taking the certification exam. Miners participating in the CWXSP must fill out the Miner Identification Document which requires approximately 20 minutes. There are about 5,000 miners participating in the CWXSP Program. Mine operators are required to file a Mine x-ray Plan with NIOSH approximately every 3 years. It takes the mine operator approximately 30 minutes to complete this form. Approximately 200 mine operators have x-ray plans that are due for renewal each year. An x-ray facility that applies to be a NIOSH-approved facility for providing miners x-rays must complete an approval packet. The forms associated with this approval process require approximately 30 minutes for completion. There are approximately 25 x-ray facilities each year seeking approval into the CWXSP Program. Overall, there will be no costs to study participants. mstockstill on PROD1PC66 with NOTICES ESTIMATES OF ANNUALIZED BURDEN HOURS Number of respondents Respondents Physicians/interpretations ................................................................................ VerDate Aug<31>2005 17:42 Aug 01, 2007 Jkt 211001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Average burden/response (in hrs.) Number of responses/ respondent 10,000 E:\FR\FM\02AUN1.SGM 1 02AUN1 3/60 Total burden (in hrs.) 500 42415 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices ESTIMATES OF ANNUALIZED BURDEN HOURS—Continued Average burden/response (in hrs.) Number of responses/ respondent Number of respondents Respondents Total burden (in hrs.) Physicians/certification ..................................................................................... Miners .............................................................................................................. Mine operators ................................................................................................. X-ray facilities .................................................................................................. 300 5000 200 25 1 1 1 1 10/60 20/60 30/60 30/60 50 1,666 100 13 Total .......................................................................................................... ........................ ........................ ........................ 2,329 Dated: July 27, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7–15027 Filed 8–1–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2008 AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2008 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA), authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2008. For FY 2008, the animal drug user fee rates are: $172,500 for an animal drug application; $86,250 for a supplemental animal drug application for which safety or effectiveness data is required; $4,125 for an annual product fee; $52,700 for an annual establishment fee; and $43,900 for an annual sponsor fee. FDA will issue invoices for FY 2008 product, establishment and sponsor fees by December 30, 2007, and these invoices will be due and payable by January 31, 2008. The application fee rates are effective for applications submitted on or after October 1, 2007, and will remain in effect through September 30, 2008. Applications will not be accepted to review until FDA has received full VerDate Aug<31>2005 17:42 Aug 01, 2007 Jkt 211001 payment of application fees and any other animal drug user fees owed. FOR FURTHER INFORMATION CONTACT: Visit the FDA Web site at https://www.fda.gov/ oc/adufa or contact Roxanne Schweitzer, Center for Veterinary Medicine (HFV–10), Food and Drug Administration, 7529 Standish Pl., Rockville, MD 20855, 240–276–9705. For general questions, you may also email the Center for Veterinary Medicine (CVM) at cvmadufa@fda.gov. SUPPLEMENTARY INFORMATION: I. Background Section 740 of the act (21 U.S.C. 379j– 12) establishes four different kinds of user fees: (1) Fees for certain types of animal drug applications and supplements, (2) annual fees for certain animal drug products, (3) annual fees for certain establishments where such products are made, and (4) annual fees for certain sponsors of animal drug applications and/or investigational animal drug submissions (21 U.S.C. 379j–12(a)). When certain conditions are met, FDA will waive or reduce fees (21 U.S.C. 379j–12(d)). For FY 2004 through FY 2008, the act establishes aggregate yearly base revenue amounts for each of these fee categories. Base revenue amounts established for years after FY 2004 are subject to adjustment for inflation and workload. Fees for applications, establishments, products, and sponsors are to be established each year by FDA so that the revenue for each fee category will approximate the level established in the statute, after the level has been adjusted for inflation and workload. II. Revenue Amount for FY 2008 and Adjustments for Inflation and Workload A. Statutory Fee Revenue Amounts ADUFA (Public Law 108–130) specifies that the aggregate revenue amount for FY 2008 for each of the four animal drug user fee categories is $2,500,000, before any adjustments for inflation or workload are made (21 U.S.C. 379j–12(b)(1)–(4)). PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 B. Inflation Adjustment to Fee Revenue Amount ADUFA provides that fee revenue amounts for each FY after 2004 shall be adjusted for inflation (see 21 U.S.C. 379j–12(c)(1)). The adjustment must reflect the greater of the following: (1) The total percentage change that occurred in the Consumer Price Index (CPI) for all urban consumers (all items; U.S. city average) during the 12-month period ending June 30 preceding the FY for which fees are being set, or (2) the total percentage pay change for the previous FY for Federal employees stationed in Washington, DC. ADUFA provides for this annual adjustment to be cumulative and compounded annually after FY 2004 (21 U.S.C. 379j– 12(c)(1)). The inflation adjustment for FY 2005 was 4.42 percent. This was the greater of the CPI increase during the 12-month period ending June 30, 2004, (3.27 percent) or the increase in pay for FY 2004 for Federal employees stationed in Washington, DC (4.42 percent). The inflation adjustment for FY 2006 was 3.71 percent. This was the greater of the CPI increase during the 12-month period ending June 30, 2005, (2.53 percent) or the increase in pay for FY 2005 for Federal employees stationed in Washington, DC (3.71 percent). The inflation adjustment for FY 2007 was 4.32 percent. This was the greater of the CPI increase for the 12-month period ending June 30, 2006, (4.32 percent) or the increase in pay for FY 2006 for Federal employees stationed in Washington, DC (3.44 percent). The inflation adjustment for FY 2008 is 2.69 percent. This is the greater of the CPI increase for the 12-month period ending June 30, 2007, (2.69 percent) or the increase in pay for FY 2007 for Federal employees stationed in Washington, DC (2.64 percent). Compounding these amounts (1.0442 times 1.0371 times 1.0432 times 1.0269) yields a total compounded inflation adjustment of 16.01 percent for FY 2008. E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42414-42415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15027]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-07-0020]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email 
to omb@cdc.gov.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Coal Workers' X-ray Surveillance Program (CWXSP) OMB  
0920-0020--Extension--The National Institute for Occupational Safety 
and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The CWXSP is a federally mandated program under the Federal Mine 
Safety and Health Act of 1977, Public Law 95-164. The Act provides the 
regulatory authority for the administration of the CWXSP, a 
surveillance program to protect the health and safety of underground 
coal miners. This Program requires the gathering of demographic and 
logistical information from coal mine operators, participating miners, 
participating x-ray facilities, and participating physicians. The 
Appalachian Laboratory for Occupational Safety and Health (ALOSH), 
located in Morgantown, WV, is charged with administration of this 
Program. Over the past two years, participation in the CWXSP has 
increased, which is reflected in this submission for renewal. Based on 
an average of 5,000 x-rays coming into the Program per year (each x-ray 
receives two readings), and using the average hourly wage rates taken 
from the Bureau of Labor Statistics, National Occupational Employment 
and Wage Estimates, the total annualized burden hours is 2,329. 
Physicians (B Readers) will fill out forms regarding their 
interpretations of the x-rays. Based on prior practice it takes the 
physician approximately 3 minutes per form. Physicians taking the B 
Reader Examination are asked to complete a registration form which 
takes approximately 10 minutes to complete. There are approximately 300 
physicians each year taking the certification exam.
    Miners participating in the CWXSP must fill out the Miner 
Identification Document which requires approximately 20 minutes. There 
are about 5,000 miners participating in the CWXSP Program. Mine 
operators are required to file a Mine x-ray Plan with NIOSH 
approximately every 3 years. It takes the mine operator approximately 
30 minutes to complete this form. Approximately 200 mine operators have 
x-ray plans that are due for renewal each year. An x-ray facility that 
applies to be a NIOSH-approved facility for providing miners x-rays 
must complete an approval packet. The forms associated with this 
approval process require approximately 30 minutes for completion. There 
are approximately 25 x-ray facilities each year seeking approval into 
the CWXSP Program. Overall, there will be no costs to study 
participants.

                                      Estimates of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of        burden/      Total burden
                   Respondents                      respondents     responses/     response  (in     (in hrs.)
                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
Physicians/interpretations......................          10,000               1            3/60             500

[[Page 42415]]

 
Physicians/certification........................             300               1           10/60              50
Miners..........................................            5000               1           20/60           1,666
Mine operators..................................             200               1           30/60             100
X-ray facilities................................              25               1           30/60              13
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           2,329
----------------------------------------------------------------------------------------------------------------


    Dated: July 27, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E7-15027 Filed 8-1-07; 8:45 am]
BILLING CODE 4163-18-P
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